ziprasidone hydrochloride
These highlights do not include all the information needed to use ziprasidone safely and effectively. See full prescribing information for ziprasidone. Ziprasidone Hydrochloride Capsules for Oral use Initial U.S. Approval: 2001
Approved
Approval ID
e05f08d9-682b-4113-bfa1-d0e351e30fa1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 13, 2013
Manufacturers
FDA
TYA Pharmaceuticals
DUNS: 938389038
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ziprasidone hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64725-0259
Application NumberANDA077565
Product Classification
M
Marketing Category
C73584
G
Generic Name
ziprasidone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2013
FDA Product Classification
INGREDIENTS (20)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ziprasidone hydrochlorideActive
Quantity: 80 mg in 1 1
Code: 216X081ORU
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT